Audit Nonconformance - Not following Control Plan - How to answer Request for CA?

L

LORIBROWN - 2006

#1
During an audit one of the employees (who was certified) told the auditor they didn't leak test the master as the control plan stated. This was wrote up as a finding for not following control plan.

This same employee 1 week prior demonstrated to the supervisor he knew how to perform the process and even signed the training form stating he understood.

I'm struggling with how to answer this non-conformance. Does anyone have any advice?
 
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Miner

Forum Moderator
Staff member
Admin
#2
LORIBROWN said:
During an audit one of the employees (who was certified) told the auditor they didn't leak test the master as the control plan stated. This was wrote up as a finding for not following control plan.

This same employee 1 week prior demonstrated to the supervisor he knew how to perform the process and even signed the training form stating he understood.

I'm struggling with how to answer this non-conformance. Does anyone have any advice?
From your description, training is not a root cause, so retraining is not an option. You need to find out why the operator chose not to leak test the master. While it might be willful negligence, it might also be because this operator is aware of a problem with the equipment that he feels is not being addressed. You will only determine this by interviewing the operator and making it clear that he will not be disciplined. If it was wilfull, he probably has a long established track record. If he is a normally reliable employee, he may be using the auditor to force action he has otherwise not been able to obtain.
 

Wes Bucey

Quite Involved in Discussions
#3
Lots of advice - will ALL parties follow it?

LORIBROWN said:
During an audit one of the employees (who was certified) told the auditor they didn't leak test the master as the control plan stated. This was wrote up as a finding for not following control plan.

This same employee 1 week prior demonstrated to the supervisor he knew how to perform the process and even signed the training form stating he understood.

I'm struggling with how to answer this non-conformance. Does anyone have any advice?
  1. So, number one on the list is to talk to employee and confirm his version of what he said to auditor.
  2. If the versions differ, who you going to believe? (My money would be on my own employee unless incontrovertable proof is offered by auditor (witness, audio or video tape, signed confession from your employee, etc.)
  3. IF the versions are the same, you have to find out if it is true. Do the staff neglect to perform this activity? Why?
  4. IF it is not true, you merely have to explain it was all a case of misperception [or sabotage - your decision] and move on.
  5. IF it is true, you have to determine a root cause, a corrective action, implement the corrective action, and make plans to re-evaluate to make sure the corrective action worked. THIS is what you report as CA to answer a nonconformance finding proven to be valid.
Above all, do not panic; do not berate the employee; do not ASSUME anything! Check everything out to assure accuracy and validity BEFORE taking any action.
 
#4
In addition........

could it be that the operator has adjusted the frequency of the master check, thinking that because the equipment is robust enough to not do it so often?

I agree that training is not an option and prefer that you investigate the motives for such an answer to the auditor.

Andy
 

Jim Wynne

Staff member
Admin
#5
LORIBROWN said:
During an audit one of the employees (who was certified) told the auditor they didn't leak test the master as the control plan stated. This was wrote up as a finding for not following control plan.

This same employee 1 week prior demonstrated to the supervisor he knew how to perform the process and even signed the training form stating he understood.

I'm struggling with how to answer this non-conformance. Does anyone have any advice?
There have been some good and perceptive answers thus far, but I'd like to warn against discounting poor training. The fact that the employee acknowledged (and perhaps demonstrated) that he knew the procedure doesn't mean he understood why it needs to be done. "Because I told you to" isn't good training, and in order to make sure that important steps aren't skipped it's important that people understand what purpose is being served.

Take this, along with all the rest of the good advice here, and use it to do an objective investigation of what happened and why--it really is an "opportunity for improvement."
 
L

LORIBROWN - 2006

#6
My investigation so far:

1) the operator says he doesn't remember being trained on this although he signed that he was.
2) His technician says he did demonstrate he could follow the control plan, that this particular individual forgets..

My thoughts so far to have some sort of re-validation to monitor retention, but not sure what root cause would be listed as.
 

Wes Bucey

Quite Involved in Discussions
#7
LORIBROWN said:
My investigation so far:

1) the operator says he doesn't remember being trained on this although he signed that he was.
2) His technician says he did demonstrate he could follow the control plan, that this particular individual forgets..

My thoughts so far to have some sort of re-validation to monitor retention, but not sure what root cause would be listed as.
Unless the operator has been brain damaged or slipped into early Alzheimer's, the root cause seems to lie in the sufficiency of evaluation of sufficiency and retention of training.

Frequently, trainers give subtle clues for the next step in a multi-step process when administering the "final" evaluation of the operator's competency to perform a task. One way around this is to have a neutral third party administer the competency exam. Next, a method should be in place to periodically review the operator at work to observe whether he follows the method taught in training or has created his own method (together with a reason why HIS method is more suited to the task.) At that point, some hard thinking is required to determine if the operator's modification is, indeed, "better," or whether he needs to be disabused of the idea.

Bottom line:
Management needs to assure training is adequate and that it "sticks" with the trainee. This means periodic re-evaluation of the competency and of the consistency in following work instructions.

Some organizations consider the concept of "mistake proofing" the work instructions by requiring a sign off or other evidence that steps have been completed BEFORE the operators can move on to the next step.

At all times, training must include emphasis on the importance of performing the work according to the preset plan, no allowance for "freelance" modification of work instructions.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
So much good input here.

I agree it sounds as though Kirkpatrick's 4th level of training assessment--results--may reveal the training indeed did not completely "stick".

Educators have learned that there's a limit to retention; reinforcement of instruction, hands on application and linking the learning to related tasks helps students remember. However, it doesn't always work. I've approached some reasons why in this article. http://elsmar.com/Forums/showthread.php?t=12122

So, a thoughtful examination of various factors should be conducted. The more important details are, the more practical are visuals and ready procedures, including flow charts and sign off sheets. Are these performance aids being used? Is it clear that this leak test is very important and why?

How often is the leak test scheduled? A week is long enough to lose retention of some lessons or details within them.

Suppose it is a training matter. Does the student operator have a processing disorder (who knows? Sometimes the subject person doesn't know).

Is the trainer delivering manageable chunks of material in comfortable environments, with respect to learning styles and giving frequent hands-on reinforcement?

Is the student operator perhaps preoccupied with a personal matter like financial problems or a family medical crisis? Might his attention have wandered at some moment during the run through (demonstrating the task and "proving" training was effective) and he is afraid to say so now?

So many questions, so little time... Please do the 5-Whys with a Cause and Effect analysis and explore this matter thoroughly enough to ensure:

1. The operator is the right person for the job.
2. The trainer is sufficiently expert, spirited and organized enough to deliver and assess adequately.
3. Errorproofing aids are being used where practical so people don't have to remember trivia or peruse manuals that look like dictionaries just to do their jobs.
4. Employees come to work ready for work, and the environment helps them do their work well.
5. Employees are able and not afraid to tell you when something is amiss.
 

Wes Bucey

Quite Involved in Discussions
#9
Yes!
Good advice, Jennifer!

If we learn anything at all from Deming's Red Bead "Experiment," it is to look at the process before blaming the operator.

Think of the concept as "Process R & R" just like "Gage R & R" (Gage Repeatability and Reproducibility)
(In the early days of DOS and Windows, I used to have a mousepad with all sorts of "tips & tricks" laminated under the surface for instant reference - maybe this work operation needs something similar as a memory jogger.)
 
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